Glaucoma Screening

NCT ID: NCT06186388

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2024-05-15

Brief Summary

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* The primary objective of this study is to evaluate the diagnostic accuracy of the TEMPO (iMOvifa) visual field perimeter screening test by measuring the sensitivity in a population of eyes with glaucoma and the specificity in a population of normal eyes and to measure repeatability of the screening test.
* The secondary objective of this study is to gather and analyze ancillary data to confirm the diagnosis or absence of glaucoma.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pathology

Subjects with glaucoma-affected eyes

Group Type OTHER

TEMPO iMOvifa

Intervention Type DIAGNOSTIC_TEST

Screening test with 28 testing points

Normal

Subjects with healthy eyes

Group Type OTHER

TEMPO iMOvifa

Intervention Type DIAGNOSTIC_TEST

Screening test with 28 testing points

Interventions

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TEMPO iMOvifa

Screening test with 28 testing points

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Subjects 40 years of age or older on the date of informed consent.
* Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
* BCVA 20/40 or better in both eyes.


* IOP ≤ 21 mmHg
* Healthy anterior and posterior segment evaluation on clinical examination.


• Diagnosis of glaucoma on clinical examination.

Exclusion Criteria

* Unable to tolerate ophthalmic imaging and/or diagnostic testing.
* History of intraocular surgery (uncomplicated surgeries are accepted).
* Ocular diseases including uveitis, non-glaucomatous optic neuropathy, severe or proliferative diabetic/ hypertensive retinopathy (controlled diabetes and hypertension participants with no or mild to moderate retinopathy \[not involving the macula\] can be included), unresolved trauma.
* Any neurodegenerative diseases including Alzheimer, Parkinson, or dementia, or history of stroke.
* Unreliable VF testing and/or poor-quality OCT scans.
* Poor fixation.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cape Fear Eye Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Jones

Role: STUDY_DIRECTOR

Clinical Research Coordinator

Locations

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Cape Fear Eye Institute

Wilmington, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CF-2023-01

Identifier Type: -

Identifier Source: org_study_id

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